Pegylated Liposomal Doxorubicin and Docetaxel in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
Stopped early · Phase 2
Conditions studied: Breast Cancer
In brief
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them before surgery may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving liposomal doxorubicin together with docetaxel before surgery and to see how well it works in treating women with locally advanced breast cancer that can be removed by surgery.
Key facts
- Study ID
- NCT00524459
- Run by
- Roswell Park Cancer Institute
- People needed
- 6
- Starts
- 2007-05-01
- Last updated by the study team
- 2014-08-29
Who can join
Age: any, up to 64. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- Menopausal status not specified
- ECOG performance status 0-2
- Life expectancy ≥ 10 years
- Platelet count ≥ 100,000/mm³
- ANC ≥ 1,500/mm³
- Hemoglobin ≥ 9.0 g/dL
- Bilirubin normal
- AST or ALT normal
- Alkaline phosphatase normal
- Serum creatinine normal
- Negative pregnancy test
- Fertile patients must use effective contraception (e.g., abstinence, intrauterine device, barrier device with spermicide, or surgical sterilization) during and for 3 months after completion of study therapy
- Normal cardiac function by LVEF or MUGA scan
- Patients with prior non-breast malignancies are eligible if they have been disease-free for ≥ 10 years
- The following are allowed even if diagnosed within the past 10 years:
- Squamous or basal cell carcinoma of the skin that has been effectively treated
- Carcinoma in situ of the cervix that has been treated by operation only
- Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by segmental resection only
You may not qualify if…
- Pregnant or lactating women
- Male patients
- Hyperbilirubinemia
- Female patients with 1 or more of the following conditions:
- Ulceration, erythema, infiltration of the skin (complete fixation), or peau d'orange (edema) of any magnitude
- Tethering or dimpling of the skin or nipple inversion should not be interpreted as skin infiltration
- Ipsilateral lymph nodes that are clinically fixed to one another or to other structures (N2 disease)
- Bilateral malignancy or a mass in the opposite breast suspicious for malignancy, unless there is biopsy proof that the mass is not malignant
- Suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless there is biopsy evidence that these are not involved with the tumor
- Nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study therapy
- Active cardiac disease that would preclude the use of doxorubicin hydrochloride, including any of the following:
- Documented myocardial infarction
- Angina pectoris that requires the use of antianginal medication
- History of documented New York Heart Association class II-IV heart failure
- Valvular disease with documented cardiac function compromise
- Poorly controlled hypertension (i.e., diastolic BP > 100 mm Hg)
- Patients with well-controlled hypertension and on medication are eligible for study
- Psychiatric or addictive disorders that would preclude obtaining informed consent
- PRIOR CONCURRENT THERAPY:
- Inclusion criteria:
- Concurrent noncancer therapies allowed if used for conditions other than breast cancer
- Adjuvant therapy after surgery allowed
- Exclusion criteria:
- Prior radiotherapy, chemotherapy, immunotherapy, and/or hormonal therapy for breast cancer
- Prior anthracycline therapy for any condition
Where it is running
- Roswell Park Cancer Institute — Buffalo, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.